MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION HURRICANE RX; CATHETER, BILIARY, DIAGNOSTIC

Model Number	M00545900
Medical Device Problem Codes	Burst Container or Vessel (1074); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0402 captures the reportable event of a balloon burst.Block h11: investigation results the hurricane rx dilatation balloon device was not returned as it was reported to be unknown.A technical analysis could not be performed.However, a media analysis was performed on the video provided by the complainant where it can be observed that the balloon shows evidence of leakage.No other problems with the device were noted.According to the media analysis performed, it was inconclusive to determine the reported event based on the video, for this reason and due to the lack of evidence it is unable to confirm the reported event of ballon burst.However, based on the evidence provided, it was reported that the leak may be associated with procedural factors, including but not limited to excessive pressure application, interaction with other devices, or anatomical conditions.Additionally, contact with a sharp surface during or prior to the procedure may have contributed to the observed damage in the distal section of the balloon.The investigation concluded that, the most probable root cause is an adverse event related to procedure.A risk review was completed and confirmed that the event of "balloon burst" was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.A review of the device history record (dhr) was performed.The review of the dhr identified that there were no process related non-conformances, scrap, or rework performed during the production that could explain the event.The reviews ensure each device meets specification prior to release for use.There is no indication the device manufacturing process contributed to the reported complaint.Review of the instructions for use (ifu) confirmed there was relevant content and sufficient guidance with respect to the circumstances described within this complaint.No updates are required to the ifu as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that a hurricane rx dilatation balloon was attempted to be used in the biliary tract during a dilatation procedure performed for the treatment of stenosis performed on (b)(6) 2026.During the procedure, the balloon was used but subsequently ruptured at 4 atm and leakage observed from the side of the balloon.A video of the complaint device was provided by the customer and showed that the balloon was leaking.It was reported that no piece of the balloon detached inside the patient.The procedure was completed with another hurricane rx dilatation balloon.There were no patient complications reported as a result of this event.

• Brand Name: HURRICANE RX
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORK LIMITED; cork business technology park; model farm road; cork T12 Y K88; EI T12 YK88
• Manufacturer Contact: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; 9145716918
• MDR Report Key: 25272446
• Report Number: 3005099803-2026-02061
• Device Sequence Number: 9167600
• Product Code: FGE
• UDI-Device Identifier: 08714729283812
• UDI-Public: (01)08714729283812(17)270704(10)36898362
• Combination Product (Y/N): N
• Initial Reporter Country: LO
• PMA/510(K) Number: K130484
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/25/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M00545900
• Device Catalogue Number: M00545900
• Device Lot Number: 0036898362
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2026
• Initial Report FDA Received Date: 05/25/2026
• Date Device Manufactured: 07/04/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown